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Regulatory Compliance Business Process Lead 

This position provides systemic, technical and organizational direction to ensure regulatory compliance for the site. The incumbent will be responsible for technical projects and reports., They will be required to serve as a liaison between Bayer/Myerstown and the Food and Drug Administration (FDA), the Drug Enforcement Agency (DEA), and any other applicable health and regulatory agencies etc.  Collaboration with regards to in product transfer is necessary. Management of consumer complaint practices and technical implementations driven by sales/marketing is required.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role are to: 

• Effectively interprets Government regulations and makes decisions regarding qualifications/validations, standard practices and Myerstown’s procedures (SOPs);
• Monitors and trends internal compliance audits and cGMP training;
• Monitors for and promotes a culture of continuous quality improvement for increased process reliability, regulatory compliance and customer satisfaction;
• Evaluates compliance programs to determine effectiveness/efficiency, such as, Batch Record Review programs, Complaint Handling programs, System Qualification/Validation programs, Deviation, Complaints and CAPA programs with associated trending etc;
• Evaluates and approves all plant deviations, including out of specification investigation reports;
• Collaborates in product transfers to/from Myerstown facility. Interact with third party regulatory groups in all matters related to compliance and quality;
• Supports the development, implementation, and validation of automated systems;
• Coordinates the auditing and monitoring of Myerstown production to ensure cGMP compliance, including qualifications/validations, cleanliness and adequacy of packaging and/or manufacturing operations;
• Coordinates recall/product correction projects as needed;
• Interfaces with support QA personnel as well as Operations on deviations, laboratory OOS investigations and complaints;
• Serves as the primary contact and audit coordinator for Bayer internal auditors, Corporate Technical Audits, State GMP Health inspections, FDA, DEA and foreign GMP auditors;
• Provides quality oversight to ensure that all plant operations satisfy government and corporate regulations and guidelines;
• Provides support in the compilation of CMC sections of New Drug Application (NDA), submissions. Actively prepares the plant for Pre-Approval Inspections (PAIs);
• Oversees compliance to Bayer Directives as they relate to local SOPs and associated implementation;
• Provides technical support to Consumer Relations on product complaints;
• Prepares and provides documented explanation and evidence of adherence to Federal Regulations to FDA, DEA and third parties when required;
• Manages  plant regulatory registrations, certifications and licensures;
• Assess Quality and Site Training;
• Manages Metrics;
• May serve  as a back-up to the Manager of QA Documentation.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required:

• BS degree in Chemistry, Microbiology, or Pharmacy;
• Knowledge of government regulations and GMP;
• Sound knowledge in chemical and analytical disciplines, understanding of microbiology, pharmaceutical technology, stability testing, physical inspection techniques and statistical methodology;
• A working knowledge of statistics and computerization (electronic documentation) of QA data;
• Excellent interpersonal skills, oral and written communication skills;
• Good problem-solving and decision-making skills;
• Ability to collaborate and navigate between the plant, senior and global leadership;
• Shares Quality budget responsibility in the $15 Mio range;
• Proven ability to use quality judgment, make rapid decisions, and carefully collect and weight all facts before recommending actions;
• Ability to make GMP recommendations that will have a significant impact on the plant quality activities, from receiving material through in-process products, testing and finished packaged goods;
• Versatility, flexibility and/or adaptability when faced with a wide variety of problems ranging from very complex and technical to rather general procedural or specification developmental types of problems;
• Strong leadership and conflict resolution skills for diverse areas of the organization with the ability to  clarify and establish regulatory corrective actions and guidance;
• Ability to independently relies on  own efforts, the QA organization and upper management to maintain the plant in constant state of regulatory compliance and control;
• Supports the Site Directors of Quality Control/Assurance as required.

Preferred:

• At least 10 years of supervisory experience in a regulated industry or laboratory (including supervising professional level scientists) or, Master's degree and at least 6 years’ experience as outlined above or PhD and at least 4 yrs experience as outlined above;
• Completion of a rotational assignment.

This job is available for application until April 28, 2025.